This is what you will do: The Global Study Associate Manager (GSAM) is a role within Development Operations and is a member of the global study team supporting delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.
The GSAM works with internal and external partners to deliver delegated aspects of the clinical study and responsibilities include assisting global study teams, leading administrative activities, overseeing systems for compliance tracking, and providing support for vendor oversight. Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).
You will be responsible for: In collaboration with the global study team (GPD, GSAD, GSM's), other ARDU stakeholders, and key vendors, support activities for clinical study execution, ensuring adherence to timelines and quality standards.Take a leading role in preparing study documents and documents related to key vendors, such as the Vendor Oversight Plan.Actively maintain and facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.Collaborate closely with both internal and external partners to effectively execute delegated aspects of the clinical study, ensuring alignment with the objectives set by the GPD, GSAD, or GSM.Actively contribute to the planning and execution of both internal and external meetings.Take a proactive role in identifying risks and issues and contribute to the development of mitigation and action plans.Provide support to the GSM in project and budget management, adhering to agreed-upon delegation.Actively participate in or take a leadership role in departmental initiatives and/or Subject Matter Expert (SME) functions.Serve as a mentor and guide for team members, promoting their professional development and cultivating a collaborative work environment.Provide support for other study and functional activities as assigned.You will need to have: Bachelor's degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).Excellent organizational communication and time management skills.Highly proactive and willing to take initiative.Strong relationship building skills.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have: 3+ years supporting global study teams in a clinical research environment.Ability to drive discussions around the scope of work and oversee vendor related activities.Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.Demonstrated ability to collaborate as well as work independently.Project management skills and basic PM methodology.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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